Ventilation mask with integrated piloted exhalation valve

• US 9,038,635 B2
• Filed: 03/13/2013
• Issued: 05/26/2015
• Est. Priority Date: 06/22/2011
• Status: Active Grant

• Current Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Original Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Inventors: Brambilla, Enrico
• Primary Examiner(s): DOUGLAS, STEVEN O
• Application Number:
  US13/798,931
• Publication Number:
  US 20130190643A1
• Time in Patent Office: 804 Days
• Field of Search: 128/207.13, 128/201.13, 128/205.24, 128/207.18
• US Class Current: 128/207.13
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/097 Devices for facilitating collection of breath or for directing breath into or through measuring devices
• CPC Class Codes: A61M 16/0066 Blowers or centrifugal pumps
• CPC Class Codes: A61M 16/0069 the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 16/1045 Devices for humidifying or heating the inspired gas by using recovered moisture or heat from the expired gas
• CPC Class Codes: A61M 16/20 Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 16/201 Controlled valves
• CPC Class Codes: A61M 16/206 Capsule valves, e.g. mushroom, membrane valves
• CPC Class Codes: A61M 16/207 Membrane valves with pneumatic amplification stage, i.e. having master and slave membranes
• CPC Class Codes: A61M 2210/0618 Nose

Abstract

The disclosure is directed to various tubing arrangements and an associated Y-connector which may be used to facilitate the operative interface of the mask to a ventilator within a ventilation system. The tubing arrangement may comprise a pair of bi-lumen tubes. One end of each of the bi-lumen tubes is fluidly connected to the mask, with the opposite end being fluidly connected to the Y-connector. The Y-connector is in turn fluidly connected to one end of either a tri-lumen tube or a quad-lumen tube also included in the tubing arrangement, the opposite end of such tri-lumen tube or quad-lumen tube being fluidly connected to the ventilator. The Y-connector is uniquely configured to fluidly connect certain lumens of the tri-lumen tube or the quad-lumen tube to dedicated, corresponding ones of the lumens included in respective ones of the bi-lumen tubes, and to further allow for the selective detachment of the tri-lumen tube or the quad-lumen tube from the bi-lumen tubes.

Claims

1. A respiratory assistance system, comprising:

a flow generator;

a ventilation mask; and

a fluid conduit fluidly coupling the flow generator to the ventilation mask, and comprising;

a multi-lumen tube which is fluidly coupled to the flow generator;

a first bi-lumen tube which has a generally teardrop-shaped cross-sectional configuration, and is fluidly coupled to and extends between the multi-lumen tube and the ventilation mask; and

a second bi-lumen tube which has a generally teardrop-shaped cross-sectional configuration, and is fluidly coupled to and extends between the multi-lumen tube and the ventilation mask.

2. The respiratory assistance system of claim 1 wherein:

the multi-lumen tube defines at least a gas delivery lumen, a valve pilot lumen and a pressure sensing lumen which are each fluidly coupled to the flow generator;

the first bi-lumen tube defines a gas delivery lumen which is fluidly coupled to and extends between the gas delivery lumen of the multi-lumen tube and the ventilation mask, and a pressure sensing lumen which is fluidly coupled to and extends between the pressure sensing lumen of the multi-lumen tube and the ventilation mask; and

the second bi-lumen tube defines a gas delivery lumen which is fluidly coupled to and extends between the gas delivery lumen of the multi-lumen tube and the ventilation mask, and a valve pilot lumen which is fluidly coupled to and extends between the valve pilot lumen of the multi-lumen tube and the ventilation mask.

3. The respiratory assistance system of claim 2 wherein the multi-lumen tube is a quad-lumen tube which has a generally circular cross-sectional configuration and further defines an auxiliary lumen.

4. The respiratory assistance system of claim 3 wherein the valve pilot, pressure sensing and auxiliary lumens of the quad-lumen tube are arranged about the gas delivery lumen thereof in equidistantly spaced intervals of about 120°

.

5. The respiratory assistance system of claim 4 wherein the gas delivery lumen of the quad-lumen tube has a generally cloverleaf shaped cross-sectional configuration, and each of the pressure sensing, valve pilot and auxiliary lumens thereof has a generally circular cross-sectional configuration.

6. The respiratory assistance system of claim 2 further comprising:

a Y-connector which is fluidly coupled to the multi-lumen tube and each of the first and second bi-lumen tubes, the Y-connector being sized and configured to facilitate the fluid coupling of the gas delivery lumen of the multi-lumen tube to the gas delivery lumens of the first and second bi-lumen tubes, facilitate the fluid coupling of the pressure sensing lumens of the multi-lumen tube and the first bi-lumen tube to each other, and facilitate the fluid coupling of the valve pilot lumens of the multi-lumen tube and the second bi-lumen tube to each other;

the Y-connector including at least first and second members which are releasably connectable to each other as allows for the selective detachment and separation of the multi-lumen tube from each of the first and second bi-lumen tubes.

7. The respiratory assistance system of claim 6 wherein:

the Y-connector comprises male and female members;

the male member of the Y-connector is coupled to the multi-lumen tube;

the female member of the Y-connector is fluidly coupled to each of the first and second bi-lumen tubes; and

the male and female members are configured so as to be releasably attachable to each other only in a manner wherein the gas delivery lumens of the multi-lumen tube and the first and second bi-lumen tubes are placed into fluid communication with each other, the pressure sensing lumens of the multi-lumen tube and the first bi-lumen tube are placed into fluid communication with each other, and the valve pilot lumens of the multi-lumen tube and the second bi-lumen tube are placed into fluid communication with each other.

8. The respiratory assistance system of claim 2 wherein:

the gas delivery lumen of each of the first and second bi-lumen tubes has a generally elliptical, oval shaped cross-sectional configuration;

the pressure sensing and valve pilot lumens of respective ones of the first and second bi-lumen tubes each have a generally circular cross-sectional configuration; and

the pressure sensing and valve pilot lumens of the first and second bi-lumen tubes are separated from respective ones of the gas delivery lumens thereof by a corresponding web portion.

9. The respiratory assistance system of claim 8 wherein the ventilation mask comprises:

a first connector and a pressure port disposed in side-by-side relation to each other, the first connector having a generally circular cross-sectional configuration;

a second connector and a pilot port disposed in side-by-side relation to each other, the second connector having a generally circular cross-sectional configuration;

the relative orientations between the first connector and the pressure port, the second connector and the pilot port, the gas delivery and pressure sensing lumens of the first bi-lumen tube, and the gas delivery and pilot lumens of the second bi-lumen tube being specifically selected so as to achieve a prescribed offset between the axes of the first and second connectors and corresponding ones of the gas delivery lumens of the first and second bi-lumen tubes when the pressure and pilot ports of the mask are coaxially aligned with respective ones of the pressure sensing and pilot lumens of the first and second bi-lumen tubes, as facilitates the resilient compression of the web portion of each of the first and second bi-lumen tubes when the first and second connectors are advanced into respective ones of the gas delivery lumens of the first and second bi-lumen tubes.

10. The respiratory assistance system of claim 9 wherein:

the relative orientations of the gas delivery and pressure sensing lumens of the first bi-lumen tube are the same as those of the gas delivery and pilot lumens of the second bi-lumen tube; and

the relative orientations of the first connector and the pressure port are the same as those of the second connector and the pilot port.

11. A respiratory assistance system, comprising:

a flow generator;

a ventilation mask; and

a fluid conduit fluidly coupling the flow generator to the ventilation mask, and comprising;

a multi-lumen tube which defines at least a gas delivery lumen, a valve pilot lumen and a pressure sensing lumen which are each fluidly coupled to the flow generator;

a first bi-lumen tube which defines a gas delivery lumen and a pressure sensing lumen which are each fluidly coupled to the ventilation mask; and

a second bi-lumen tube which defines a gas delivery lumen and a pilot lumen which are each fluidly coupled to the ventilation mask; and

a Y-connector which is fluidly coupled to the multi-lumen tube and each of the first and second bi-lumen tubes, the Y-connector being sized and configured to facilitate the fluid coupling of the gas delivery lumen of the multi-lumen tube to the gas delivery lumens of the first and second bi-lumen tubes, the fluid coupling of the pressure sensing lumens of the multi-lumen tube and the first bi-lumen tube to each other, and the fluid coupling of the valve pilot lumens of the multi-lumen tube and the second bi-lumen tube to each other;

the Y-connector including at least first and second members which are releasably connectable to each other as allows for the selective detachment and separation of the multi-lumen tube from each of the first and second bi-lumen tubes.

12. The respiratory assistance system of claim 11 wherein:

the Y-connector comprises male and female members;

the male member of the Y-connector is coupled to the multi-lumen tube;

the female member of the Y-connector is fluidly coupled to each of the first and second bi-lumen tubes; and

the male and female members are configured so as to be releasably attachable to each other only in a manner wherein the gas delivery lumens of the multi-lumen tube and the first and second bi-lumen tubes are placed into fluid communication with each other, the pressure sensing lumens of the multi-lumen tube and the first bi-lumen tube are placed into fluid communication with each other, and the valve pilot lumens of the multi-lumen tube and the second bi-lumen tube are placed into fluid communication with each other.

13. The respiratory assistance system of claim 11 wherein:

the gas delivery lumen of each of the first and second bi-lumen tubes has a generally elliptical, oval shaped cross-sectional configuration; and

the pressure sensing and valve pilot lumens of the first and second bi-lumen tubes are separated from respective ones of the gas delivery lumens thereof by a corresponding web portion.

14. The respiratory assistance system of claim 13 wherein the ventilation mask comprises:

a first connector and a pressure port disposed in side-by-side relation to each other, the first connector having a generally circular cross-sectional configuration;

a second connector and a pilot port disposed in side-by-side relation to each other, the second connector having a generally circular cross-sectional configuration;

the relative orientations between the first connector and the pressure port, the second connector and the pilot port, the gas delivery and pressure sensing lumens of the first bi-lumen tube, and the gas delivery and pilot lumens of the second bi-lumen tube being specifically selected so as to achieve a prescribed offset between the axes of the first and second connectors and corresponding ones of the gas delivery lumens of the first and second bi-lumen tubes when the pressure and pilot ports of the mask are coaxially aligned with respective ones of the pressure sensing and pilot lumens of the first and second bi-lumen tubes, as facilitates the resilient compression of the web portion of each of the first and second bi-lumen tubes when the first and second connectors are advanced into respective ones of the gas delivery lumens of the first and second bi-lumen tubes.

15. The respiratory assistance system of claim 14 wherein:

the relative orientations of the gas delivery and pressure sensing lumens of the first bi-lumen tube are the same as those of the gas delivery and pilot lumens of the second bi-lumen tube; and

the relative orientations of the first connector and the pressure port are the same as those of the second connector and the pilot port.

16. A respiratory assistance system, comprising:

a flow generator;

a ventilation mask; and

a fluid conduit fluidly coupling the flow generator to the ventilation mask, and comprising;

a quad-lumen tube which is fluidly coupled to the flow generator and defines a gas delivery lumen, a valve pilot lumen, a pressure sensing lumen and an auxiliary lumen;

a first multi-lumen tube which defines at least a gas delivery lumen which is fluidly coupled to and extends between the gas delivery lumen of the quad-lumen tube and the ventilation mask, and a pressure sensing lumen which is fluidly coupled to and extends between the pressure sensing lumen of the quad-lumen tube and the ventilation mask; and

a second multi-lumen tube which defines at least a gas delivery lumen which is fluidly coupled to and extends between the gas delivery lumen of the quad-lumen tube and the ventilation mask, and a valve pilot lumen which is fluidly coupled to and extends between the valve pilot lumen of the quad-lumen tube and the ventilation mask.

17. The respiratory assistance system of claim 16 further comprising:

a Y-connector which is fluidly coupled to the quad-lumen tube and each of the first and second multi-lumen tubes, the Y-connector being sized and configured to facilitate the fluid coupling of the gas delivery lumen of the quad-lumen tube to the gas delivery lumens of the first and second multi-lumen tubes, the fluid coupling of the pressure sensing lumens of the quad-lumen tube and the first multi-lumen tube to each other, and the fluid coupling of the valve pilot lumens of the quad-lumen tube and the second multi-lumen tube to each other.

18. The respiratory assistance system of claim 16 wherein the valve pilot, pressure sensing and auxiliary lumens of the quad-lumen tube are separated from each other by intervals of approximately 120°

, and each have a generally circular cross-sectional configuration.

19. The respiratory assistance system of claim 16 wherein the quad-lumen tube includes a reinforcement ribbon which is embedded therein and extends along at least a portion thereof.

20. The respiratory assistance system of claim 16 wherein:

the gas delivery lumen of each of the first and second multi-lumen tubes has a generally elliptical, oval shaped cross-sectional configuration; and

the pressure sensing and valve pilot lumens of the first and second multi-lumen tubes are separated from respective ones of the gas delivery lumens thereof by a corresponding web portion.